RISE Pediatric Medication Study (RISE Peds)

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ClinicalTrials.gov Identifier: NCT01779375

Recruitment Status :
Completed

First Posted : January 30, 2013

Results First Posted : October 8, 2018

Last Update Posted : October 10, 2018

Sponsor:

RISE Study Group

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin.

The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.

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Layout table for eligibility information

Ages Eligible for Study:

10 Years to 19 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Fasting plasma glucose ≥90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus laboratory-based HbA1c ≤8.0% if treatment naïve. There is no upper limit for the 2-hour glucose on OGTT. In those taking metformin laboratory-based HbA1c must be ≤7.5% if on metformin for <3 months and ≤7.0% if on metformin for 3-6 months.

Age 10-19 years

Pubertal development Tanner stage >1 as defined by breast stage >1 in girls, and testes >3 cc's in boys.

Body mass index (BMI) ≥85th percentile but ≤50 kg/m2

Self-reported diabetes <6 months in duration

Treatment with metformin for <6 months preceding screening

Exclusion Criteria:

Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment

An underlying disease that affects glucose metabolism other than type 2 diabetes mellitus

Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications

Anemia (hemoglobin <11 g/dl in girls, <12 g/dl in boys) or known coagulopathy

Cardiovascular disease, including uncontrolled hypertension defined as average systolic or diastolic blood pressure > 99 percentile for age or >135/90, despite adequately prescribed antihypertensive medications. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies.

History of conditions that may be precipitated or exacerbated by a study drug:

Serum alanine transaminase (ALT) more than 3 times the upper limit of normal

Excessive alcohol intake

Sub-optimally treated thyroid disease

Conditions or behaviors likely to affect the conduct of the RISE Study

Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE

Weight loss of ≥5% of body weight in the past 3 months for any reason other than post-partum weight loss. Participants taking weight loss drugs or using preparations taken for intended weight loss are excluded.

Likely to move away from participating clinics in next 2 years

Current (or anticipated) pregnancy and lactation.

A pregnancy that was completed less than 6 months prior to screening.

Breast feeding within 6 months prior to screening.

Women of childbearing potential who are unwilling to use adequate contraception

Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE

Additional conditions may serve as criteria for exclusion at the discretion of the local site.